Impressum  
     
 

Click on the following links for detailed information on selected projects:

Computer System Validation (CSV) for pharmaceutical production process

GxP-conforming quality management system for major hospital pharmacy

21 CFP Part 11 Compliance Pharma laboratory systems for production and analysis

21 CFP Part 11 Compliance consolidation

SIP – Strategic Information Planning and Personnel Management

Click here for a detailed summary of our projects.

 

   
  21 CFP Part 11 Compliance Pharmaceutical Production and Research Laboratory Systems
Goal
Analysis, evaluation and possible adaptation of all pharmaceutical production and research laboratory systems in view of their compliance with 21 CFR Part 11.
Method
Registration of all computer systems, systematic analysis and evaluation of all systems in view of 21 CFR Part 11 compliance, assessment of supplier proposals, management of necessary upgrades and replacement of systems including documentation (URS, FS, DS, validation test documentation); support for implementation; training.
Result
21 CFR Part 11 Compliance for all systems.
Duration

1 year